FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: CELLULAR, TISSUE, AND GENE THERAPIES ADVISORY COMMITTEE; NOTICE OF MEETING; ESTABLISHMENT OF A PUBLIC DOCKET; REQUEST FOR COMMENTS-BIOLOGICS LICENSE APPLICATION (BLA) 125827, FROM REPLIMUNE, INC. FOR VUSOLIMOGENE ODERPAREPVEC

WASHINGTON, July 8 -- Food and Drug Administration has issued a notice called: Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec.

The notice was published in the Federal Register on July 8 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issue...